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Electronic common technical document
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251	December 3, 2010 Notice Our file Number: [removed]Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents in Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:49:31 Research Electronic documents Technology Medical informatics Electronic Common Technical Document Digital media Common Technical Document Portable Document Format Health Canada Clinical Data Management Computing Clinical research
252	Notice - New requirements for submitting administrative regulatory activities (submissions) to Health Canada Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:49:31 Research Medical informatics Electronics ISO standards Electronic Common Technical Document Digital media Common Technical Document Electronic submission Portable Document Format Clinical Data Management Computing Clinical research
253	Microsoft Word - Sample eCTD.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Medical informatics Electronic Common Technical Document Food and Drug Administration Computer file formats Computing Clinical research Research
254	Notice - E2C(R2): Periodic Benefit Risk Evaluation Report (PBRER) Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:53:03 Research Drug safety Medical informatics Electronic Common Technical Document Pharmacology Common Technical Document Pharmacovigilance Health Canada Clinical Data Management Medicine Clinical research
255	FDA Regional Technical Specifications for ICH E2B (R3) Implementation Postmarket Submission of Individual Case Safety Reports (ICSRs) for Vaccines Draft Technical Specifications Document This Document is incorporated by Add to Reading List Source URL: www.fda.gov Language: English Drug safety Research Medical informatics Clinical research Clinical Data Management Vaccine Adverse Event Reporting System Structured Product Labeling Electronic Common Technical Document Adverse Event Reporting System Medicine Health Food and Drug Administration
256	Federal Register / Vol. 76, No[removed]Wednesday, October 26, [removed]Notices Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301 Add to Reading List Source URL: www.novoco.com Language: English - Date: 2013-07-30 13:37:35 Food and Drug Administration Medicine Historic preservation Medical informatics Electronic Common Technical Document Common Technical Document United States Department of Homeland Security Advisory Council on Historic Preservation Homeland security Clinical Data Management Clinical research Research
257	FDA Electronic Submissions Gateway (ESG) Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Pharmaceutical sciences Electronic Common Technical Document AS2 New Drug Application Electronic submission Title 21 CFR Part 11 Biologic License Application Food and Drug Administration Clinical research Pharmaceutical industry
258	FDA IT and Informatics Transformation Add to Reading List Source URL: www.fda.gov Language: English Clinical research Cloud computing Electronic Common Technical Document Cloud infrastructure Apache Hadoop ECRM Computing Centralized computing Clinical Data Management
259	Microsoft Word - notice-avis_vaccine-vaccin-eng.doc Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:44:53 Pharmaceutical industry Health Canada Medical informatics Electronic Common Technical Document Common Technical Document Health Products and Food Branch Clinical Data Management Research Clinical research
260	Microsoft Word - Wood PharmaSUG[removed]SEND[removed]doc Add to Reading List Source URL: www.pharmasug.org Language: English - Date: 2011-05-06 09:49:36 Science Clinical Data Management Pharmacology Medical informatics SDTM Clinical Data Interchange Standards Consortium Electronic Common Technical Document Clinical trial Nonclinical studies Research Clinical research Food and Drug Administration

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